NCT05070208Completed
Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date. The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 400 (actual)
- First submitted
- 27 Sept 2021
- Start date
- 22 Sept 2021
- Primary completion date
- 25 Jan 2024
- Lead sponsor
- Acute Leukemia French Association
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05070208
What you commit to
- Study type: Observational
- Participants enrolled: 400
- From 22 Sept 2021 to the primary completion date, 25 Jan 2024
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Opposition expressed to research
Who the study is looking for
- Patients over 18 years old
- Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
- Initial management by intensive chemotherapy, hypomethylants or targeted therapies
Age in the registry: 18 years to - · Sex: All
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| AP-HP-GHU - Hôpital AVICENNE Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU de la cote de Nacre Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CH Métropole-Savoie Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| Hôpital Militaire Percy Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| Henri Mondor Aphp Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Dijon Chu Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre Hospitalier de Dunkerque Coordinator of this site? Confirm its status | Dunkirk | France | Unknown status |
| Centre Hospitalier de Versailles André Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Unknown status |
| LENS CHR Coordinator of this site? Confirm its status | Lens | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Limoges - CHU Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHU La Conception Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU Nice,Hopital Archet 1 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Pitié-Salpêtrière - APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Necker - APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Saint-Louis - APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Centre Hospitalier Rene Dubos Coordinator of this site? Confirm its status | Pontoise | France | Unknown status |
| Centre hospitalier de Roubaix Coordinator of this site? Confirm its status | Roubaix | France | Unknown status |
| Centre Hospitalier de St Quentin Coordinator of this site? Confirm its status | Saint-Quentin | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.